Batch Record Reviewer (m/w/d) — Coopers Group AG

Full description

We are looking for a candidate with a first experience within Quality Assurance in the biopharmaceutical industry.

What you’ll do

• Perform timely and independent review of executed electronic batch records (eBRs) in MES Syncade.
• Ensures that operations batch records are accurately executed, complete, and ready for QA review.
• Collaborate with Manufacturing and Quality teams to clarify and resolve documentation issues
• Initiate and support in the management of Quality Records (CAPAs and Deviations) for Batch Record review related observations.
• Support preparation of documentation package to enable fast release by QA.

What we’re looking for

• Previous experience in GDP and GMP regulated pharmaceutical / API industry.
• Experience in batch record review (preferred eBR) OR in manufacturing is required.
• Ability to identify non-compliance and gaps from quality standards.
• Very good communication skills and interaction with all kinds of interfaces within the organization; strong team orientation.
• Structured, focused and well-organized working attitude.
• Open-minded for new ideas and suggestions; solution-oriented.
• Agile, highly motivated and dynamic drive.
• Ability to produce reliable results under stress.

Job profile

• Life Sciences - Quality Management
• Wallis
• Contracting
• Full Time
• Quality Assurance